Cadence IV pain drug approved

Cadence Pharmaceuticals has won US FDA approval for Ofirmev, the first intravenous formulation of acetaminophen to be marketed in the US

Cadence Pharmaceuticals has won US Food and Drug Administration (FDA) approval for Ofirmev, which will become the first and only intravenous formulation of acetaminophen to be marketed in the United States.

The drug, which is intended for use in adults and children in hospital settings when oral medication can't be used, is indicated for the management of mild to moderate pain, the management of moderate to severe pain with adjunctive opioid analgesics, and the reduction of fever.

The FDA earlier rejected the drug, which was formerly known as Acetevance, in February of this year because of deficiencies at a Mississippi plant operated by Cadence's third-party manufacturer, Baxter International.

Cadence acquired the exclusive rights to Ofirmev in the US and Canada in 2006 from Bristol-Myers Squibb, which markets the product as Perfalgan in Europe and other parts of the world.

During a conference call with investors to discuss the US approval, Scott Byrd, Cadence's chief commercial officer, said that the drug's performance in the European Union (EU) made the company very optimistic about the US launch. "IV acetaminophen has been widely adopted in the markets where it has been launched such as the EU," he said. Bristol-Myers launched the product in the EU in 2002, where it has become the market-leading injectable pain medication, he said.

Byrd said Cadence has recruited and is in the process of hiring 150 sales reps to support the launch, and is also assembling a team of medical science liaisons to support the formulary review process at hospitals. The company expects to launch the drug in the US in the first quarter of 2011 and will announce specific launch plans and pricing at a later date, he said.

The marketing application for Ofirmev included data from clinical trials in which 1,020 adult and 355 paediatric patients received IV acetaminophen. Two studies evaluated Ofirmev in the treatment of pain, and one evaluated the drug in fever.

A study of about 100 orthopaedic patients undergoing hip or knee replacement surgery who were given Ofirmev every six hours found that the drug was statistically superior to placebo for the reduction of pain intensity over 24 hours and significantly reduced the need for morphine consumption. A study of adult volunteers with induced fever showed that a single dose of Ofirmev reduced temperature better than placebo, with an onset of action within 15 minutes.

Ofirmev has not yet been studied in patients younger than two years old. During the conference call, Cadence chief medical officer Jim Breitmeyer said that the company plans to begin a post-marketing efficacy study in infants and newborns next year, which it expects will result in an extension of patent protection under the Pediatric Exclusivity programme.

The drug will be Cadence's first marketed product. In March 2009, it ceased development of its only other product, Omigard, a treatment to prevent catheter-related infections, after the failure of a phase III trial.